US8129138B2 - Method and apparatus for determining an analyte in a liquid sample - Google Patents

Method and apparatus for determining an analyte in a liquid sample Download PDF

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Publication number
US8129138B2
US8129138B2 US12/478,878 US47887809A US8129138B2 US 8129138 B2 US8129138 B2 US 8129138B2 US 47887809 A US47887809 A US 47887809A US 8129138 B2 US8129138 B2 US 8129138B2
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Prior art keywords
measuring
signal
analyte
liquid sample
test system
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Expired - Fee Related, expires
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US12/478,878
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US20090305332A1 (en
Inventor
Erich Haendler
Norbert Oranth
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Roche Diagnostics Operations Inc
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Roche Diagnostics Operations Inc
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Assigned to ROCHE DIAGNOSTICS GMBH reassignment ROCHE DIAGNOSTICS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ORANIN, NORBERT, HAENDLER, ERICH
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/557—Immunoassay; Biospecific binding assay; Materials therefor using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody

Definitions

  • the invention relates to a method for the determination of an analyte in a liquid sample, especially a body liquid sample, as well as to an analytical apparatus and a computer program product.
  • the determination of an analyte in the liquid sample can also comprise, in addition to the basic detection of the analyte itself, the measuring of analyte-specific properties in the liquid sample.
  • the liquid sample to be examined is customarily applied on a test system or test element with several analyte detection zones that are also designated as measuring- or examination areas.
  • the applied liquid sample moves here along a straight line on which the several measuring areas or detection zones are arranged.
  • Analyte-specific catch structures are arranged in the measuring areas that can have a circular, rectangular or linear form, so that a part of the analyte from the liquid sample is bound in the measuring areas.
  • the analyte or analytes is/are customarily labeled directly or via antibodies and as a result are prepared for a subsequent optical evaluation of the test system.
  • a preparation of the test system or test element can optionally comprise the cleaning or washing with a puffer solution, diluting solution or a wash solution.
  • the test system that is, for example, a dry chemical test element, can then be evaluated by optical sampling in order in particular to determine the occurrence of one or more certain analytes in the measuring areas.
  • measuring light beams produced in the scanned examination areas are detected with a detector apparatus after leaving the examination areas.
  • the measuring light beams can be produced by radiating test light beams produced for their part by a suitable monochromatic or polychromatic light source onto the measuring areas charged with optically active substances to be measured. In the measuring areas the light of the test light beams then interacts with the optically active substances so that a corresponding change of the optical properties of the test light beams results that then leave the measuring area as measured light beams.
  • the absorption, the transmission, the reflection or also the fluorescence can be examined as optical properties of the measuring light beams.
  • measuring light beams can be based on a luminescence of the optically active substances in the measuring areas.
  • test element and the detector apparatus which detects the measuring light beams or the test element and the light source can be shifted relative to one another in order to optically analyze measuring area after measuring area in this manner.
  • the measuring areas are optically examined with the aid of optical measuring methods such as absorption, fluorescence, transmission or reflection in order to analyze the binding of the analytes in a particular zone.
  • the so-called test light beams are put on the measuring area that then interact in the measuring area with optical labels that bind to the analyte-specific catch structures, as a result of which the measuring light beams are produced, that are detected with the aid of an optical detector apparatus.
  • a photodiode or a photodiode arrangement can serve as such optical detector apparatuses.
  • the signals measured for the measuring light beams are used in order to determine, for example, a concentration or other properties of the analyte in the liquid sample.
  • the detected measuring light beams are customarily dependent on the binding efficiency with which a complex of the analyte flowing past the measuring area or the detection zone binds there to the catch structures.
  • the binding efficiency is for its part generally dependent on different properties such as the type of the substrate (membrane) used for the measuring area, the individual liquid sample, the analyte-specific catch structures or the temperature.
  • the binding efficiency is therefore very different for different measuring- or analytical situations. This means that a variation of the binding efficiency usually directly affects the result of analysis.
  • a concentration measure N correlating with the concentration of the analyte in the liquid sample is determined by the evaluation apparatus in accordance with the following linkage of measuring signals:
  • N ( s j ) i + 2 [ s i - ( ( s i ) j - i - 1 ⁇ s j ) 1 j - i ] ⁇ ( ( s i ) j - i - 1 ⁇ s j ) i j - 1 , and
  • the concentration measure N is outputted by the evaluation apparatus after a selective further processing.
  • the first measuring area is an ith measuring area and the second measuring area is a jth measuring area.
  • the evaluation apparatus is furthermore configured for determining and outputting a concentration measure N correlating with the concentration of the analyte in the liquid sample in accordance with the following linkage of measuring signals:
  • N ( s j ) i + 2 [ s i - ( ( s i ) j - i - 1 ⁇ s j ) 1 j - i ] ⁇ ( ( s i ) j - i - 1 ⁇ s j ) i j - 1 .
  • FIG. 1 is schematic view of the test system with several measuring areas extending transversally to a direction of spread of a liquid sample on the test system
  • FIG. 2 shows a plot for a signal drop in the case of several successively located measuring areas or detection zones with a linear form.
  • FIG. 3 shows a plot for an error propagation.
  • An essential advantage achieved with the invention over the state of the art is that the determination of the concentration measure by the evaluation apparatus is independent of the binding efficiency for the analyte of the liquid sample in the measuring areas of the test system.
  • the suggested signal processing eliminates so to say the influence of the binding efficiency. In this manner the determination of the concentration measure for the analyte in the liquid sample is far less dependent on the analytical conditions that frequently change from situation to situation.
  • concentration measure N correlates with the concentration in such a manner that an increase of the concentration also brings about an increase of the concentration measure.
  • concentration measure correlates with the concentration in such a manner that an increase of the concentration also brings about an increase of the concentration measure.
  • concentration measure at a decrease of the concentration.
  • the correlation can be of a linear or of a non-linear nature.
  • a functional connection between concentration and concentration measure does not have to be known in a mathematically exact form here but rather the actual concentration can also be determined using an experimentally determined gauging or calibration curve.
  • the suggested technology for the determination of analytes is furthermore distinguished in that in order to evaluate the analysis based on the test system, measuring signals for any measuring areas of the test system can be used.
  • the measuring signals themselves can be detected in a known manner with the aid of a suitable detector apparatus like those known as such in various embodiments.
  • measuring signals are used for a test system in order to determine the concentration measure in which the measuring areas extend transversally to the direction of flow of the liquid sample on the test system.
  • Measuring signals can be evaluated for measuring areas with different forms, for example, of measuring areas that have a rectangular, circular or linear form.
  • the concentration measure proportional to the concentration of the analyte in the liquid sample can be selectively further processed with the aid of the evaluation apparatus in order to determine an actual concentration of the analyte as absolute or relative magnitude.
  • a further processing of the concentration measure can take place using comparison signals detected previously in the framework of a calibration or gauging.
  • a preferred further development of the invention provides that a first optical measuring signal is received as the first measuring signal and a second optical measuring signal is received as the second measuring signal.
  • the first and the second optical signals can be formed, according to a signal type, selected from the following group of signal types: fluorescence signal, transmission signal, absorption signal and reflection signal.
  • N ( s i ) i + 2 [ s i - s i + 1 ] ⁇ ( s i + 1 ) i .
  • a detector apparatus can be provided with the analytical apparatus which detector apparatus is configured to detect the first and the second measuring signal and to output them to the evaluation apparatus.
  • the detector apparatus is an optical detector apparatus that is configured to detect in an appropriate manner the first and the second optical measuring signal of a signal type selected from the following group of signal types: fluorescence signal, transmission signal, absorption signal and reflection signal.
  • test system can be integrated in the analytical apparatus in an advantageous embodiment of the invention which test system is preferably configured to be replaceable or for multiple use.
  • the test system can be a detection system with measuring areas formed separately from each other or with a cohesive measuring area that can be utilized in such a manner with measuring technology that successively arranged partial measuring areas can be utilized for the detection of the measuring signals.
  • the technologies suggested here for the determination of the concentration measure can be used for both types of test systems.
  • a further development of the invention can provide using the concentration measure determined using the first and the second measuring signal together with the result of further such analyses, in which at least one measuring signal for a further measuring area is included, for example, in the sense of a formation of mean value or average value. In this manner measuring signals are used for more than two measuring areas of the test system
  • FIG. 1 shows a schematic view of a test system 1 on which several measuring areas or detection zones M 0 , . . . , M 6 are formed along a direction of spread 2 and extending transversally to it.
  • a liquid sample especially a body liquid sample, that contains one or more analytes to be detected can be placed on the test system 1 .
  • the one or more analyte(s) is/are marked with a so-called label.
  • analyte-specific catch structures to which the analyte binds are formed in the measuring areas M 0 , . . . , M 6 .
  • the markings or labels of the bound analyte complexes can then be evaluated with measuring technology for the measuring areas M 0 , .
  • test light beams are radiated onto the measuring areas M 0 , . . . , M 6 and associated measuring light beams optically detected with the aid of a detector apparatus (not shown).
  • the different degree of shading of the measuring areas M 0 , . . . , M 6 in FIG. 1 shows the different range in which the analyte is bound in the measuring areas M 0 , . . . , M 6 .
  • the binding takes place to the greatest extent in the measuring area M 0 , in contrast to which in the last-shown measuring area M 6 only a small amount of the analyte is present in the liquid sample, for which reason only few analyte molecules or analyte structures are bound there.
  • measuring signals for measuring areas in which a start can be made from a proportionality between the number of the bound, marked analyte structures and the intensity of the measuring signal.
  • the latter can potentially not be the case, for example, especially in the first measuring areas after the application region of the test system 1 , since a falsification of measuring value can occur there on account of the high number of the bound, marked analyte structures.
  • the high density of labels can result in non-linear optical behavior.
  • measuring signals are preferably used in a purposeful manner that are located in the dynamic range of the detector apparatus, that is, the range in which the response function of the detector that is relevant according to measuring technology behaves in a linear manner.
  • the detection system preferably constructed as optical detector apparatus then furnishes measuring signals s 1 during the measuring of the measuring areas that are proportional to the number of the labels trapped in the particular measuring area, that is, to the number of the analyte elements marked and bound with a label.
  • the measuring signals s i detected in this manner for the measuring areas are then processed with the aid of an evaluation apparatus (not shown), which is, for example, a microprocessor unit configured in accordance with hardware and/or software technology, in accordance with the following signal linking:
  • the detected measure N i is proportional to m 0 , that is, to the number of the label structures that reach the first measuring area M 0 and is no longer dependent on the binding efficiency ⁇ .
  • N i ( C ⁇ m 0 ⁇ ⁇ ⁇ ( 1 - ⁇ ) i ) i + 2 ( C ⁇ m 0 ⁇ ⁇ ⁇ ( 1 - ⁇ ) i - C ⁇ m 0 ⁇ ⁇ ⁇ ( 1 - ⁇ ) i + 1 ) ⁇ ( C ⁇ m 0 ⁇ ⁇ ⁇ ( 1 - ⁇ ) i + 1 ) i ( 6 )
  • the linking of measuring signals according to equation (3) refers to the evaluation of adjacent measuring areas of the test system 1 .
  • N ij ( s j ) i + 2 [ s i - ( ( s i ) j - i - 1 ⁇ s j ) 1 j - i ] ⁇ ( ( s i ) j - i - 1 ⁇ s j ) i j - 1 , that shows a linking of measuring signals for any measuring areas of the test system 1 , that allows the determination of the concentration measure N ij independently of the binding efficiency ⁇ .
  • N i or N ij as measure for the analyte concentration can be further examined using the following considerations. If the effect of a variation of the binding efficiency ⁇ is observed according to the law of error propagation, a comparative observation with other linkings of measuring signals shows:
  • the measuring signals in the measuring of the detection zone become all the smaller the further to the rear (viewed in the direction of flow/spread) the particular detection zone is located.
  • the preferably optically executed detection can be adjusted so that in the case of very high analyte concentrations the number of the label measuring area n 0 is so high that the detection system is in the limitation at these measuring areas, thus, a saturation of the detector occurs.
  • N i would be determined from the measuring signals for two detection zones or measuring areas at which the measuring signal had dropped so far that it falls in the optimal working range of the detector, thus, advantageously the linear working range.
  • very low concentrations would be determined from the measuring signals of the last two measuring areas.
  • FIG. 3 The dynamic expansion associated therewith is visualized in FIG. 3 .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
US12/478,878 2008-06-05 2009-06-05 Method and apparatus for determining an analyte in a liquid sample Expired - Fee Related US8129138B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08010289A EP2131197B1 (de) 2008-06-05 2008-06-05 Verfahren zum Bestimmen eines Analyten in einer Flüssigkeitsprobe und Analysevorrichtung
EP08010289 2008-06-05
EP08010289.0 2008-06-05

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US8129138B2 true US8129138B2 (en) 2012-03-06

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US (1) US8129138B2 (es)
EP (1) EP2131197B1 (es)
JP (1) JP5002616B2 (es)
CN (1) CN101598663B (es)
AT (1) ATE481643T1 (es)
CA (1) CA2668221C (es)
DE (1) DE502008001323D1 (es)
ES (1) ES2349390T3 (es)
HK (1) HK1139459A1 (es)

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WO2012071044A1 (en) * 2010-11-24 2012-05-31 Inanovate, Inc. Longitudinal assay
US8975087B2 (en) 2010-11-24 2015-03-10 Inanovate, Inc. Longitudinal assay
EP2941630B1 (en) * 2013-01-07 2019-08-21 Ixensor Co., Ltd. Test strips and method for reading test strips
US9778200B2 (en) 2012-12-18 2017-10-03 Ixensor Co., Ltd. Method and apparatus for analyte measurement
EP2781919A1 (en) * 2013-03-19 2014-09-24 Roche Diagniostics GmbH Method / device for generating a corrected value of an analyte concentration in a sample of a body fluid

Citations (4)

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Publication number Priority date Publication date Assignee Title
US5723345A (en) 1994-06-28 1998-03-03 Mochida Pharmaceutical Co., Ltd. Method and device for specific binding assay
US20060155501A1 (en) * 2004-11-17 2006-07-13 Eckhard Hempel Method, apparatus, system and computer program product for selection of a static evaluation method for an empirical examination of measurement series
US7338639B2 (en) * 1997-12-22 2008-03-04 Roche Diagnostics Operations, Inc. System and method for analyte measurement
US7550069B2 (en) * 1998-10-08 2009-06-23 Abbott Diabetes Care Inc. Small volume in vitro analyte sensor

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JPH0875748A (ja) * 1994-06-28 1996-03-22 Mochida Pharmaceut Co Ltd 特異結合分析方法および装置
GB0030929D0 (en) * 2000-12-19 2001-01-31 Inverness Medical Ltd Analyte measurement
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EP1461606A4 (en) * 2001-12-05 2005-06-29 Univ Washington MICROFLUIDIC DEVICE AND SURFACE DECORATION METHOD FOR SOLID PHASE AFFINITY BINDING ASSAYS
US7132041B2 (en) * 2003-02-11 2006-11-07 Bayer Healthcare Llc Methods of determining the concentration of an analyte in a fluid test sample
JP4581898B2 (ja) * 2005-08-05 2010-11-17 パナソニック株式会社 試験片測定装置

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US5723345A (en) 1994-06-28 1998-03-03 Mochida Pharmaceutical Co., Ltd. Method and device for specific binding assay
US7338639B2 (en) * 1997-12-22 2008-03-04 Roche Diagnostics Operations, Inc. System and method for analyte measurement
US7550069B2 (en) * 1998-10-08 2009-06-23 Abbott Diabetes Care Inc. Small volume in vitro analyte sensor
US20060155501A1 (en) * 2004-11-17 2006-07-13 Eckhard Hempel Method, apparatus, system and computer program product for selection of a static evaluation method for an empirical examination of measurement series

Non-Patent Citations (3)

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Title
Hanen, "Principles and Applications of Flow Injection Analysis in Biosensors", Journal of Molecular Recognition, 9:216-325 (1996).
Holbrook, et al., "Protein Fluorescence of Lactate Dehydrogenase", Biochemical Journal, 128:921-931 (1972).
Schult, et al., "Disposable Optical Sensor Chip for medical Diagnostics: New Ways in Bioanalysis", Analytical Chemistry, 71:5430-5435 (1999).

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Publication number Publication date
ES2349390T3 (es) 2010-12-30
JP2009294211A (ja) 2009-12-17
EP2131197A1 (de) 2009-12-09
JP5002616B2 (ja) 2012-08-15
US20090305332A1 (en) 2009-12-10
EP2131197B1 (de) 2010-09-15
ATE481643T1 (de) 2010-10-15
HK1139459A1 (en) 2010-09-17
CN101598663A (zh) 2009-12-09
CA2668221C (en) 2015-11-24
DE502008001323D1 (de) 2010-10-28
CN101598663B (zh) 2012-06-27
CA2668221A1 (en) 2009-12-05

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